Clinical trial

Akkermansia Muciniphilia and Metabolic Side Effects of ADT

Recruiting now · Early Phase 1 · 1 countries · Registry ID NCT05802121

Recruiting nowEarly Phase 1Interventional

What this study is about

The overriding objectives of this study are: 1. Primary outcomes: 1. To confirm that administration of oral acetate increases the proportion of A. muciniphilia in the stool samples of patients with metastatic, castration-sensitive prostate cancer compared to a standard of care arm. 2. To confirm tolerability and assess for side effects of oral acetate supplementation. 2. Secondary outcomes: 1. To determine if increased counts of A. muciniphilia correlate with improved metabolic parameters and improved bone health.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexMale
Healthy volunteersNot accepted
ConditionProstate Cancer, Metabolic Syndrome, Obesity, Cardiovascular Morbidity, Bone Diseases, Hyperlipidemias, Diabetes

Full registry criteria

For inclusion in this study, patients must fulfill all of the following criteria: 1. Men ≥18 years of age with histologically-proven metastatic castration-sensitive prostate adenocarcinoma planned to receive ADT (TNM stage Tany, Nany, M1) (see Appendix I). 2. Must have baseline imaging with 1) CT of the abdomen, and pelvis and bone scan or 2) PSMA PET scan Patients fulfilling any of the following criteria are NOT eligible for participation in this study: 1. Age less than 18 2. Primary neuroendocrine prostate cancer 3. Treatment with ADT within the year leading up to enrolment 4. Planned or concurrent use of chromium supplementation for the study duration 5. Planned or concurrent use of apple cider vinegar supplementation for the study duration 6. Unable to provide informed consent or unable to understand or read the English language (unless accompanied by an interpreter) 7. Inadequate liver function (\>2x upper limit of normal) 8. Any other condition, chronic disease, or lifestyle factor, that, in the opinion of the Qualified Investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant 9. Use of antibiotics that cannot be discontinued for a washout period and remain off them for the duration of the trial

Treatments and study arms

Apple Cider Vinegar

Drug

Each patient will be instructed to take 1 caplet (equivalent of 143 mg/caplet containing 36% acetic acid) per day for 3 months (NPN: 80078433) https://www.jamiesonvitamins.com/products/apple-cider-vinegar-chromium?srsltid=AfmBOoqdVBFe83\_5JM9BmkomQM1LqsJYSFTiP\_78cnmehfzVg-4T4Z6o

Primary outcomes

Fecal Akkermansia muciniphilia counts1 week

Counts of Akkermansia muciniphilia in participant stool samples at 1 week following the intervention will be compared to baseline counts.

Fecal Akkermansia muciniphilia counts1 month

Counts of Akkermansia muciniphilia in participant stool samples at 1 month following the intervention will be compared to baseline counts.

Fecal Akkermansia muciniphilia counts3 month

Counts of Akkermansia muciniphilia in participant stool samples at 3 months following the intervention will be compared to baseline counts.

Fecal Akkermansia muciniphilia counts4 month

Counts of Akkermansia muciniphilia in participant stool samples at 4 months following the intervention will be compared to baseline counts.

Fecal Akkermansia muciniphilia counts6 month

Counts of Akkermansia muciniphilia in participant stool samples at 6 months following the intervention will be compared to baseline counts.

Side effects and tolerability3 months

We will record side effects reported by the participants and the rate of Discontinuation of the intervention.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

London Health Sciences Centre - Victoria Hospital🇨🇦 London, Ontario, Canada